ALE.C04 + pembrolizumab

ALE.C04 + pembrolizumab is an investigational combination therapy currently in phase 1/2 development for the treatment of recurrent or metastatic Claudin-1 (CLDN1)–positive head and neck squamous cell carcinoma (HNSCC)[1][2][4][5][6]. ALE.C04 is a first-in-class monoclonal antibody designed to selectively bind exposed Claudin-1 (CLDN1) on cancer cells. The antibody functions by remodeling the extracellular matrix, enhancing T-cell and NK-cell trafficking into the tumor, directly mediating tumor cell killing through effector functions, and restoring anti-PD-1 activity in immune-excluded tumors, which may help overcome resistance to immune checkpoint inhibitors[5][6]. Pembrolizumab (brand name Keytruda) is a programmed death-1 (PD-1) immune checkpoint inhibitor that helps the immune system recognize and destroy cancer cells. The combination aims to leverage the complementary mechanisms of ALE.C04's enhancement of immune cell infiltration and pembrolizumab's checkpoint blockade to maximize anti-tumor immunotherapy effects[1][5][6]. Development is led by Alentis Therapeutics. The combination is administered intravenously on a three-week (Q3W) schedule, with the goal of improving objective response, progression-free survival, and overall survival in patients with advanced head and neck cancers[1][2][3][4][5][6].

Other names

ALE.C04 + Keytruda